Strict liability is not the same as absolute liability.  We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way.  The key separator between strict liability and absolute liability is comment k to section 402A of the Restatement (Second) of Torts (1965), which observes that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.”  Think of dynamite, for example.  More pertinent to our practice area, comment k included prescription drugs and vaccines among its examples.  But it did not mention medical devices.  That is probably because comment k antedated anything approximating the degree of regulation of medical devices we enjoy today.  In any event, we are left with this question: does comment k apply to medical devices?  If so, which ones?

This is not the first time that we have faced this issue.  Back in 2011, we authored a magnum opus called “Comment k, Some of the Way.”  To this day, it is one of our most widely read posts.  The question keeps cropping up, as product liability plaintiffs keep trying to minimize the scope of comment k.  One simple way of bifurcating judicial treatment of comment k is “across-the-board” versus “case-by-case,” but that misses some nuances.  In 2015, in a post charmingly entitled “How Does a Bad Idea Get Implanted?” we blasted the commonplace California plaintiff argument that comment k applied to medical devices only if they were implantable.  As we demonstrated, that argument lacked sense and support, and the real issue should be whether the medical device required a doctor’s prescription. Tongue depressors come with neither prescriptions nor comment k protection, but, say, medical lasers should come with both.  In 2017, we revisited the issue to look beyond California, finding cases in other jurisdictions applying comment k to medical devices. It is an important issue, and it keeps surfacing.  Here is another post where we scrutinized the contours of comment k. So, is it unusual for courts to apply comment k to medical devices?  Not at all.  Take a look at our favorite reference book, Beck/Vale, Drug and Medical Device Product Liability Deskbook, section 2.02[2] and footnote 14.  There are literally hundreds of cases that have applied comment k to medical devices, in the same way they apply it to prescription drugs. 

Recently, the scope of comment k surfaced in Burningham v. Wright Med. Grp., Inc., 2018 U.S. Dist. LEXIS 10726 (D. Utah Jan. 23, 2016).  In that case, the plaintiff alleged injuries from an implanted hip device.  The design defect claims were premised on a theory of strict liability.  The defendants argued that the hip implant was an “unavoidably unsafe” product and was, therefore, categorically barred from design defect claims. Utah law controlled and the Utah Supreme Court has adopted the comment k “unavoidably unsafe products” exception to strict products liability.  But while the Utah Supreme Court has explicitly applied comment k to prescription drugs (categorically, not case-by-case), it has thus far been silent on whether comment k reached medical devices.  The defendant in Burningham argued that the doctrine regarding unreasonably unsafe products should apply equally to the medical device at issue.   

The Burningham case has traveled a circuitous path through the judicial system.  It was filed in California state court, then became part of a coordinated proceeding, then was released from that proceeding, then was moved by consent to the federal court in Utah.  Meanwhile, there is a federal MDL in Georgia dealing with design defect claims against these same hip implants.  Not so long ago, we authored a screed against a decision in that litigation involving what we saw as a complete misreading of Utah law on … wait for it .. comment k.  The Georgia federal court did not apply comment k to the medical devices and, just for good measure, completely mangled Utah law on design defect.  We were disappointed. Then the Eleventh Circuit affirmed the horrible result and wretched reasoning.  We were disappointed again.

So we have some history with this topic.

You will not be surprised to hear that we agree with the defense argument that Utah law should and would include hip implant medical devices as “unavoidably unsafe” products warranting comment k protection. The Burningham court stated that the defendant pointed “to decisions from courts in Oklahoma, Washington, California, and Pennsylvania, which do apply the doctrine to implanted medical devices.”  Yikes – there’s that unnecessary/wrong restriction to implanted devices, but since the devices in Burningham definitely were implanted one can see why the defendant in that case would take the most conservative approach.  If the federal court was going to try to predict which way the Utah Supreme Court would go, the broader reading of comment k, which would include medical devices, would probably prevail. But because the “question of whether the categorical exception applies to implanted medical devices is a question of first impression for Utah courts,” the federal court sua sponte (on its own) decided to issue an order certifying the issue to the Utah Supreme Court.  Our bet is that the defense will persuade the Utah court to extend comment k to medical devices.  Just don’t dig in too hard on the question of implantation.  Leave us room later to argue that comment k should apply to all prescription medical devices, please-and-thank-you.

Meanwhile the federal court was in a perfectly fine position to dismiss the misrepresentation and breach of warranty claims for lack of reliance.  The complaint supplied conclusory allegations of generalized reliance, but never listed any factual allegations that the plaintiff or his doctors “actually read or saw Defendant’s misrepresentations” and the complaint contained “no allegation that the Defendants’ express warranties were ever communicated to Plaintiffs or Mr. Burningham‘s physicians.”  The complaint could not “withstand the Twombly/Iqbal analysis.”  So much for those claims, and now it is up to the Utah Supreme Court to read comment k correctly and pave the way for dismissal of the strict liability claims.